Adherence of Diuretics in Pulmonary Hypertension

Last updated: January 16, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

N/A

Condition

Circulation Disorders

Stress

Vascular Diseases

Treatment

No intervention (Observational cohort)

Clinical Study ID

NCT05167968
2021-A02137-34
  • Ages > 18
  • All Genders

Study Summary

In this prospective study, the investigators will implement a systematic assessment of adherence to diuretics in a cohort of patients with precapillary pulmonary hypertension.

This study is designed to:

  • determine the overall adherence rates for diuretic regimen

  • determine the determinants of non-adherence to diuretics

  • assess the risk of PH worsening occurrence in the non-adhesion group

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women over 18 years old

  • Precapillary PH

  • Diuretics treatment for at least 12 months

  • Having given his/her non-opposition to participate

Exclusion

Exclusion Criteria:

  • Treatment regimen without diuretics

  • Diuretics treatment for less than 12 months

  • Postcapillary PH

  • People refusing or unable to give informed consent

  • No affiliation to a regime of social security.

  • Protected patients

Study Design

Total Participants: 227
Treatment Group(s): 1
Primary Treatment: No intervention (Observational cohort)
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
January 24, 2024

Study Description

Introduction Precapillary pulmonary hypertension (PH) is characterized by remodeling of small pulmonary arteries leading to a progressive increase in pulmonary vascular resistance (PVR) resulting to right heart failure and ultimately death. The prognosis of PH is closely related to the ability of the right ventricle to adapt to the progressive increase in PVR. The occurrence of acute right ventricular decompensation is associated with a very poor prognosis at short term.

The management of precapillary PH is based on specific therapies combined with general measures and supportive therapies. Diuretic treatment is recommended in PAH patients with signs of RV failure and fluid retention (recommendation class I, level of evidence C). The beneficial effect of diuretics is probably essential for preventing episodes of acute right ventricular decompensation. However, no study analyzed the rate of adherence to diuretic regimen in PH patients and the impact of patterns of adherence to diuretics on the outcomes of patients.

Aim and objectives

The main objectives of this study are to:

  • determine the overall adherence rates for diuretic regimen

  • determine the determinants of non-adherence to diuretics

  • assess the risk of PH worsening occurrence in the non-adherence group

Methodology

Evaluation of subjects and adhesion to diuretics at inclusion are recorded:

  • Self-questioning of medication adherence: Girerd questionnaire

  • Assessment of the Medication Possession Ratio

  • Social and demographic data

  • Comorbidities

  • PH characteristics

  • Clinical evaluation: dyspnea assessed by NYHA functional class (New York Heart Association Functional Classification : I-IV), signs of right heart failure

  • Type of treatment regimen

  • History of serious events including non-programmed hospitalization for PH and/or worsening of the disease (15% reduction in the 6-minute walking test and worsening of the WHO functional class) and/or the need to reinforce specific PH therapies

Connect with a study center

  • Hospital Bicêtre - Pneumology department

    Le Kremlin-Bicêtre, 94275
    France

    Site Not Available

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